Architecture change PCCPs
7 of the 143 FDA-authorized PCCPs are Architecture change plans, 7 of them AI/SaMD. Here is the full list, newest first.
- K251934qXR-DetectQure.Ai Technologies2026-01-16AI/SaMDArchitecture change
- K252366a2z-Unified-TriageA2z Radiology Ai, Inc.2025-11-24AI/SaMDArchitecture change
- K252041Fibresolve (with PCCP)Imvaria, Inc.2025-11-07AI/SaMDArchitecture change
- K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.2025-09-15AI/SaMDArchitecture change
- K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.2025-06-06AI/SaMDArchitecture change
- K240953AI Platform 2.0 (AIP002)Exo Imaging2024-08-05AI/SaMDArchitecture change
- K233955Clarius OB AIClarius Mobile Health Corp.2024-06-14AI/SaMDArchitecture change
Other PCCP types
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We read the Architecture change PCCPs in this list, then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.
Book a callSource: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.
This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.